A Phase I Study of BMS-275183 Given on a Daily Schedule in Patients With Advanced Malignancies

Tumors Clinical Trial

Official title:

A Phase I Study of BMS-275183 Given on a Daily Schedule in Patients With Advanced Malignancies

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00207025
• Other study ID #: CA165-012
• Status: Terminated
• Phase: Phase 1
• First received: September 12, 2005
• Last updated: February 27, 2010
• Start date: October 2004

Study information

• Verified date: July 2008
• Source: Bristol-Myers Squibb
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

The purpose of this clinical research study is to learn about the safety and tolerability of daily BMS-275183 in patients with advanced cancer.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 60
• Est. primary completion date: February 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Non-hematologic malignancy that has progressed or no standard therapy is known

• Four weeks from last chemotherapy or two weeks from last non-cytotoxic therapy

• Eastern Cooperative Oncology Group (ECOG) Performance Status 0-1

• No more than 3 prior chemotherapy regimens in advanced/metastatic setting

• Absolute neutrophil count >=1,500/mm3 and platelets >=100,000/mm3

• Bilirubin <=1.5 x Upper Limit of Normal (ULN), Aspartate aminotransferase <=2.5 x ULN

• Serum creatinine <=1.5 x ULN

• Men and women >=18 years

• Women of Child Bearing Potential (WOCBP) must use adequate method of contraception throughout and up to 4 weeks after the study

Exclusion Criteria:

• WOCBP and men not using adequate method of birth control

• WOCBP who are pregnant or breastfeeding

• Prior radiation >=25% of bone marrow containing skeleton

• Uncontrolled, significant, or active cardiovascular or pulmonary disease or infection or psychiatric disorder

• Neuropathy

• Active brain metastases

• Inability to swallow capsules

• History of gastrointestinal disease, surgery or malabsorption, or requiring use of a feeding tube

• Concurrent chemotherapy, hormonal therapy, immunotherapy, or radiotherapy

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Tumors

Intervention

Drug:
• BMS-275183

Locations

Country	Name	City	State
Belgium	Local Institution	Brussels
United States	Local Institution	Detroit	Michigan
United States	Local Institution	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bristol-Myers Squibb

Countries where clinical trial is conducted

United States,  Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety and Tolerability
Secondary	PK, preliminary evidence of antitumor activity

External Links

•   BMS Clinical Trials Disclosure
•   For FDA Safety Alerts and Recalls refer to the following link www.fda.gov/MEDWATCH/safety.htm